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China’s NMPA approves Ascentage’s lisaftoclax for CLL/SLL

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Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) has announced that China’s National Medical Products Administration (NMPA) has approved its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors.

Lisaftoclax is the first Bcl-2 inhibitor to receive conditional approval and marketing authorization for the treatment of patients with CLL/SLL in China, and the second Bcl-2 inhibitor approved globally.

In a statement, Dr. Dajun Yang, chairman and CEO of Ascentage, commented, “Our founding team has over 20 years of research experience in the field of apoptosis and accumulated deep expertise on the Bcl-2 target. This approval for lisaftoclax is a culmination of their dedicated research and a major milestone in our never-ending journey of innovation, further solidifying our leadership in the hematology field. As a proprietary novel drug developed through global innovation, lisaftoclax is a testament to our strength in drug development, bringing much needed change to the global landscape for Bcl-2 inhibitors. Moving forward, Ascentage Pharma will remain steadfastly committed to its mission of addressing unmet clinical needs in China and around the world and aspire to bring more innovative therapeutics to more patients globally.”

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